Serum TNFα levels at 24 h after certolizumab pegol predict effectiveness at week 12 in patients with rheumatoid arthritis from TSUBAME study
Abstract Objective To estimate the relationship between serum TNFα, IL-6, and serum CZP levels and the clinical response to CZP in RA patients in the TSUBAME study. Methods One hundred patients with RA who received CZP were enrolled and multiple clinical parameters, serum TNFα, IL-6, and CZP levels,...
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| Format: | Article |
| Language: | English |
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BMC
2021-06-01
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| Series: | Arthritis Research & Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13075-021-02547-2 |
| _version_ | 1818641023986827264 |
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| author | Yusuke Miyazaki Kazuhisa Nakano Shingo Nakayamada Satoshi Kubo Shigeru Iwata Kentaro Hanami Shunsuke Fukuyo Ippei Miyagawa Ayako Yamaguchi Akio Kawabe Kazuyoshi Saito Yoshiya Tanaka |
| author_facet | Yusuke Miyazaki Kazuhisa Nakano Shingo Nakayamada Satoshi Kubo Shigeru Iwata Kentaro Hanami Shunsuke Fukuyo Ippei Miyagawa Ayako Yamaguchi Akio Kawabe Kazuyoshi Saito Yoshiya Tanaka |
| author_sort | Yusuke Miyazaki |
| collection | DOAJ |
| description | Abstract Objective To estimate the relationship between serum TNFα, IL-6, and serum CZP levels and the clinical response to CZP in RA patients in the TSUBAME study. Methods One hundred patients with RA who received CZP were enrolled and multiple clinical parameters, serum TNFα, IL-6, and CZP levels, were assessed at 0, 24, and 48 h and 12 weeks after first administration of CZP. Results The CZP therapy significantly improved the DAS28(ESR) at 12 weeks. Serum TNFα and IL-6 levels significantly decreased from baseline at 24 h after the first administration of CZP. Serum TNFα levels at baseline were not related to clinical parameters at baseline and improvement in DAS28(ESR) at week 12 of the CZP therapy. However, serum levels of CZP at 24 h were strongly and negatively correlated with TNFα levels at 24 h, which were negatively correlated with improved rate in DAS28(ESR) at week 12. Only serum levels of TNFα, but not IL-6, at 24 h had a negative correlation with achievement of DAS28(ESR)<2.6 at week 12 by the multivariate analysis (odds ratio 0.01, 95% confidence interval 0.04e−2–0.22, p < 0.01). A receiver operating characteristic analysis was conducted to estimate the achievement of DAS28(ESR)<2.6 at week 12 after the CZP therapy and cut-off value of 0.76 pg/ml for serum levels of TNFα at 24 h was yielded (area under the curve=0.75). DAS28(ESR)<2.6 was achieved at week 12 significantly more patients with lower serum TNF levels (≦0.76 pg/ml) at 24 h than those with higher TNF levels. Conclusions CZP was highly effective in RA patients who had low serum TNFα levels at 24 h after the initial administration of CZP. Therefore, we propose that serum TNFα levels at 24 h could serve as a biomarker predicting effectiveness to CZP at week 12 in patients with RA. Trial registration Clinical trial registration number: UMIN ID:000022831 |
| first_indexed | 2024-12-16T23:20:35Z |
| format | Article |
| id | doaj.art-fbfda6ffde32413abb78f9bc803da386 |
| institution | Directory Open Access Journal |
| issn | 1478-6362 |
| language | English |
| last_indexed | 2024-12-16T23:20:35Z |
| publishDate | 2021-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Arthritis Research & Therapy |
| spelling | doaj.art-fbfda6ffde32413abb78f9bc803da3862022-12-21T22:12:11ZengBMCArthritis Research & Therapy1478-63622021-06-0123111110.1186/s13075-021-02547-2Serum TNFα levels at 24 h after certolizumab pegol predict effectiveness at week 12 in patients with rheumatoid arthritis from TSUBAME studyYusuke Miyazaki0Kazuhisa Nakano1Shingo Nakayamada2Satoshi Kubo3Shigeru Iwata4Kentaro Hanami5Shunsuke Fukuyo6Ippei Miyagawa7Ayako Yamaguchi8Akio Kawabe9Kazuyoshi Saito10Yoshiya Tanaka11The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthAbstract Objective To estimate the relationship between serum TNFα, IL-6, and serum CZP levels and the clinical response to CZP in RA patients in the TSUBAME study. Methods One hundred patients with RA who received CZP were enrolled and multiple clinical parameters, serum TNFα, IL-6, and CZP levels, were assessed at 0, 24, and 48 h and 12 weeks after first administration of CZP. Results The CZP therapy significantly improved the DAS28(ESR) at 12 weeks. Serum TNFα and IL-6 levels significantly decreased from baseline at 24 h after the first administration of CZP. Serum TNFα levels at baseline were not related to clinical parameters at baseline and improvement in DAS28(ESR) at week 12 of the CZP therapy. However, serum levels of CZP at 24 h were strongly and negatively correlated with TNFα levels at 24 h, which were negatively correlated with improved rate in DAS28(ESR) at week 12. Only serum levels of TNFα, but not IL-6, at 24 h had a negative correlation with achievement of DAS28(ESR)<2.6 at week 12 by the multivariate analysis (odds ratio 0.01, 95% confidence interval 0.04e−2–0.22, p < 0.01). A receiver operating characteristic analysis was conducted to estimate the achievement of DAS28(ESR)<2.6 at week 12 after the CZP therapy and cut-off value of 0.76 pg/ml for serum levels of TNFα at 24 h was yielded (area under the curve=0.75). DAS28(ESR)<2.6 was achieved at week 12 significantly more patients with lower serum TNF levels (≦0.76 pg/ml) at 24 h than those with higher TNF levels. Conclusions CZP was highly effective in RA patients who had low serum TNFα levels at 24 h after the initial administration of CZP. Therefore, we propose that serum TNFα levels at 24 h could serve as a biomarker predicting effectiveness to CZP at week 12 in patients with RA. Trial registration Clinical trial registration number: UMIN ID:000022831https://doi.org/10.1186/s13075-021-02547-2Rheumatoid arthritisBiological therapiesDMARDsPharmacologyBiomarkers |
| spellingShingle | Yusuke Miyazaki Kazuhisa Nakano Shingo Nakayamada Satoshi Kubo Shigeru Iwata Kentaro Hanami Shunsuke Fukuyo Ippei Miyagawa Ayako Yamaguchi Akio Kawabe Kazuyoshi Saito Yoshiya Tanaka Serum TNFα levels at 24 h after certolizumab pegol predict effectiveness at week 12 in patients with rheumatoid arthritis from TSUBAME study Arthritis Research & Therapy Rheumatoid arthritis Biological therapies DMARDs Pharmacology Biomarkers |
| title | Serum TNFα levels at 24 h after certolizumab pegol predict effectiveness at week 12 in patients with rheumatoid arthritis from TSUBAME study |
| title_full | Serum TNFα levels at 24 h after certolizumab pegol predict effectiveness at week 12 in patients with rheumatoid arthritis from TSUBAME study |
| title_fullStr | Serum TNFα levels at 24 h after certolizumab pegol predict effectiveness at week 12 in patients with rheumatoid arthritis from TSUBAME study |
| title_full_unstemmed | Serum TNFα levels at 24 h after certolizumab pegol predict effectiveness at week 12 in patients with rheumatoid arthritis from TSUBAME study |
| title_short | Serum TNFα levels at 24 h after certolizumab pegol predict effectiveness at week 12 in patients with rheumatoid arthritis from TSUBAME study |
| title_sort | serum tnfα levels at 24 h after certolizumab pegol predict effectiveness at week 12 in patients with rheumatoid arthritis from tsubame study |
| topic | Rheumatoid arthritis Biological therapies DMARDs Pharmacology Biomarkers |
| url | https://doi.org/10.1186/s13075-021-02547-2 |
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